GMP Spezial

In the Chinese regulatory system for pharmaceutical products, companies are issued certificates that show them to be GMP compliant. To receive such a certificate, a company must pass an inspection based on the current GMP regulations. This inspection is carried out against an official inspection checklist that is derived from the Chinese GMP regulations. In this supplement to their translation of the “Chinese Drug GMP” Li and Kuwahara have translated and annotated the most recent edition of this checklist.

This new version of the checklist was issued by the Chinese State Food and Drug Administration as a part of their effort to increase the stringency of their GMP inspections. Since January 1, 2008, Chinese GMP inspections have been conducted by using this checklist, and the criteria for awarding a GMP certificate have been tightened.

Table of Contents:

Inspection Criteria for the Evaluation of Pharmaceutical Products for GMP Certification
Organization and Personnel
Premises and Facilities
Equipment
Materials
Hygiene and Sanitation
Validation
Documentation
Production
Quality Management
Product Distribution, Recalls, and Returns
Complaints and Adverse Reactions Report
Self-Inspection

Simon Xiuwei Li, holds a bachelor’s degree in Chemical Engineering from Tiangjin University and an MBA degree from the Macau University of Science and Technology. Li later joined the Shanghai Schering-Plough Pharmaceutical Co Ltd. where he was a production manager and senior engineer in organic synthesis. His tenure there was followed by a position with the TSI (China) Company Limited. At TSI, Li started as Operations Director and recently became the Senior Director of Quality and Regulatory. Mr. Li is experienced in technical operations and quality in the pharmaceutical industry and has written several articles for publication in China.

Dr. Steven S. Kuwahara, holds degrees in Biochemistry from Cornell University and the University of Wisconsin. He currently heads his own firm, GXP BioTechnology, LLC. Dr. Kuwahara is an experienced analytical biochemist. His work also has dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors, as well. Dr. Kuwahara has spoken at numerous industry conferences and has written many papers and book chapters.

PDA/DHI Publication